FDA Warning on Vaginal Mesh

Vaginal Mesh Complication Surgeons | Mesh Surgery

Over the past decade, the use of mesh for treatment of pelvic organ prolapse and urinary incontinence has become increasingly common secondary to trying to improve cure rates in patients who have weak native tissue where a native repair would fail. Many different companies have produced different materials and methods for gynecologic placement of mesh. Some of those products utilized show higher complication rates versus others. Type I macroporous, polypropylene mesh has been shown to be the best tolerated material to date due to its softness, porousity and tendency to assimilate to the body well. Howevever, unfortunately, complications can still occur with the best meshes under optimal surgical conditions with the best surgeons secondary to the permanent nature of the material.

Mesh has a proper indication for certain gynecolgic patient conditions and when placed by experienced surgeons, outcomes have been statistically shown to be excellent. Dr. Croak agrees with this statement and uses mesh for stress urinary incontinence (SUI) and abdominal pelvic organ prolapse (POP) repair when appropriately indicated. He takes the time to explain the pros and cons of mesh when needed.

Patients that suffer from surgical mesh complications may find difficulty in receiving adequate treatment as many surgeons are not trained to handle these problems or choose not to do so because of threat of litigation. Dr.Croak has extensive experience in the proper use of mesh and the treatment of complications when they do occur. He has removed or revised over 300 mesh complication in the past several years.

Complications that are known to occur requiring potential surgical treatment include:

Failure of the Procedure

Pain (Vagina, leg, pelvic, adbominal, sexual)

Infection or rejection of the graft material

Recurrence of prolapse and incontinence with mesh

Recurrent urinary tract infection

Extrusion of the mesh into the vagina causing pain, discharge, bleeding

Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence: FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.

FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.

The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.

In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.

Background: A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum. Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity. Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

Talking to your doctor: Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene. Questions you should ask the surgeon before you agree to surgery in which mesh will be used:

What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?

If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?

What’s been your experience in dealing with the complications that might occur?

What can I expect to feel after surgery and for how long?

Are there any specific side effects I should let you know about after the surgery?

What if the mesh doesn’t correct my problem?

If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?

If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Reporting complications to the FDA: In order to help FDA learn more about possible problems with surgical mesh, it is important that both physicians and patients report complications that may be associated with this product.

You can report any problems to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or FAX.

In 2008, the FDA put out a safety communication regarding vaginally placed mesh for pelvic organ prolapse (POP) regarding complications reported over the recent past few years. The notification and its 2011 update detailed that the FDA has received over 1,500 reports of complications during the past several years (out of approximately 250,000 vaginal mesh procedures completed) regarding vaginally placed mesh for prolapse or incontinence. Adverse events included erosion, pain, infection, bleeding, pain with intercourse, organ perforation during the surgery and urinary and/or bowel problems. Many complications potentially require further surgery or treatment and may not resolve completely. The increase in complications reported was due to more mesh surgery being performed. The communication pertained primarily to vaginal mesh placement for treatment of POP. The FDA mandated a recall in 2012 of any of the vaginally placed POP mesh products, particularly the “kits.” Companies producing vaginal mesh kits for POP did start to remove these products from the market as early as 2012.

In 2014, the FDA propsed a reclassification of vaginally placed meshes from a mild to moderate risk class II device (FDA example given of a condom) to a class III device that carries significant risk and requires pre and post market surveillance along with substantial scruntiny of performace and complications (FDA example given of a heart valve).

Although risks including but not limited to erosion, pain, and scar tissue are all risks of mesh placed abdominally for POP or vaginally for SUI, the FDA excluded sacrocolpoxies and incontinence slings from the notification as it seems that not as many complications have been reported with these procedures and there are extensive studies supporting the mesh use for these procedures, thus qualifying them as the current “gold standard” for POP and SUI surgical treatment. The use of mesh abdominally or laparoscopically (i.e. sacralcolpopexy) POP and the mesh used in slings for SUI was effectively EXCLUDED and EXHONORATED by the FDA; therefore these specific meshes were not reclassified as a high risk device.

Although there are many published studies including hundreds of patients that show excellent results with minimal complications when mesh is placed vaginally for prolapse, newer conclusions have been made that most cases of prolapse do not need mesh for successful treatment therefore eliminating the risk of mesh. If mesh is to be used at all for vaginal POP repair, risks/benefits/alternatives should be extensively reviewed with the patient and all other treatment options should be exhausted. The surgeon must ensure he/she has the proper training to correctly select patients with indications for mesh, to place vaginal mesh, and to take care of any complications that may occur.

It is important to note that NO surgery is risk free. Prolapse and incontinence surgery without mesh may be extremely complex and thus, carries similar risks of mesh augmented surgery. In many cases, non-meshed surgery carries extra risk of failure.

Therefore, this implies that it is NOT the mesh that is the problem in every instance. The problem may lie in how mesh is placed and in whom. Whether mesh is used or not, prolapse and incontinence surgery is advanced surgery and extra training and expertise is critical to obtaining good outcomes in patients.

Up until 2012, many companies marketed mesh “kits” for POP and SUI surgery as providing a “minimally invasive surgery” that “anyone” can learn. These companies trained many new surgeons on their use, most of whom have had minimal training in pelvic floor reconstruction. Altruistically, these surgeons had the goal of truly helping their patients with a very frustrating problem or recurrent prolapse or incontinence- they were looking for a better tool. Consequently, from 2002-2012, there was a great increase in these type of surgeries being performed and in many cases by non-specialists. Unfortunately, just because the procedure is in a “kit,” it does not make ithe procedure simple for everyone to perform. Most of the complications reported are in regards with these “kit” surgeries. Despite modifications and improvements to some of these kits, issues complications still arose. It does seem to be very clear that many of the complications reported can be minimized tremendously by proper surgeon experience and training. However, risks of surgery will FDA approved or recalled mesh will always be present. The FDA, the American Urogynecologic Society (AUGS), the Society of Urodynamics Female Pelvic Medicine and Urogenital Reconstruction (SUFU) and the American Association of Gynecologic Laparoscopists have all resleased official position statements supporting FDA approved mesh usage and all have recommended improved training, credentialing and monitoring by hospitals on who should be completing these procedures, which will help decrease complications.

Dr. Croak supports mesh use in POP and SUI surgery for the right patient. He has used it for many years in his practice with excellent outcomes and has reported his results in the peer reviewed medical journals. Dr. Croak will continue to use mesh when indicated, while appropriately providing informed consent of potential risks of mesh as well as alternatives such as biologic grafts. Without using augmentative materials, Dr. Croak would not get high cure rates when compared to “traditional” surgery without mesh in people with poor tissue strength. He supports the FDA notification entirely. The Northwest Ohio Center for Urogynecology and Women’s Health wishes to make themselves readily available to their colleagues and patients to assist with any issues or concerns regarding mesh complications. Many complications are small extrusions and may be simply handled if they are addressed early and appropriately!

If litigation, either class-action or directed, is being considered by the patient, it is imperative that they inform Dr. Croak of this consideration.

He is sympathetic to every patients’ situation but will need to review the case individually, and does reserve the right to decline acceptance of care. Please understand that Dr. Croak needs to do his job as a physician and keep his priorities on his office and hospital practice first and foremost. By taking on mesh complication cases out of his willingness to help those with problems, he unfortunately has been forced to delegate an ever increasingly disproportionate amount of time towards subsequent litigatory efforts. This is not why Dr. Croak became a physician. It is with great reluctance, that as litigation regarding mesh complications has increased, Dr. Croak has begun to limit the cases he will see because of this burden to his practice. To put this sensitive point in perspective, several of the best and largest academic medical centers in the country have recently instituted policies of refusing to even see mesh complications if their surgeons did not perform the original surgery.

Please be expected to sign a waiver relinquishing Dr. Croak from any and all risk of litigation if you wish to have him assist you with your situation.